Zpráva o průběhu neintervenční observační studie Ponderosa Annual Report Sledované období: 5. červenec 2020 – 3. červenec 2021
| Title in English | Ponderosa Progress report of a non - interventional observational study Annual Report Observed period: July 5, 2020 - July 3, 2021 |
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| Year of publication | 2021 |
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| Description | Ponderosa - Observational study on CML patients in any phase treated with ponatinib (Iclusig®) at any dose study Interim Report: The first annual report of the observational study describes in detail the course of the approval process and subsequent activities in the observed period. The annual report includes information on the whole initial approval process of the study by ethics committees in individual centers, as well as subsequent approval of documents that were approved or taken into account by ethics committees in the given period, an overview of activated centers in the Czech Republic (address, principal examiners and dates of centers initiation), enrollment and reporting of the first patient to the ethics committee, the number of patients enrolled in each center, the incidence of serious adverse reactions and reports, identified protocol violations and information on newly identified properties on the investigational medicinal product in relation to its safety and efficacy. The second annual report of the observational study contains data about the recruitment of subjects in individual clinical trial centers, the incidence of serious adverse reactions and reporting, identified protocol violations and information on newly identified findings on the investigational medicinal product in relation to its safety and efficacy. The goal is to include in total 15 subjects in 6 clinical trial centers in the Czech Republic. So far, 23 patients have been enrolled, and recruitment continues after verification with the sponsor. |
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